CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Busulfan +3 moredrug
Likely dose
Campath 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00943319
NCT00943319Phase 2Completed
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A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

University of Chicago·interventional·Posted Jul 22, 2009·Updated Feb 4, 2019

In Brief

A Phase 2 clinical trial evaluating Busulfan, Fludarabine, and 2 other interventions for Leukemia and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma, Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2009
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2017
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.9 years ago

Interventions

Busulfandrug

Daily intravenous dosing to target AVC

Fludarabinedrug

Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.

Campathdrug

All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).

Stem Cell Transplantprocedure

Infusion of bone marrow and donors(related/ unrelated).